BEUDAMED
    FDA Recall Open, Classified

    FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

    Recall: Z-1518-2025 · Initiated February 27, 2025

    Recall

    Recall Number
    Z-1518-2025
    Event Number
    96346
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    QDS
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 27, 2025
    Posted
    April 4, 2025
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    Description

    FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

    Reason

    Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

    Action

    On February 28, 2025, Biomerieux issued an "Urgent Field Safety Notice" Recall notification to affected consignees via email. The notice described the product, problem and actions to be taken. Biomerieux asked consignees to take the following actions: " Immediately examine your inventory for the lot identified in this field safety notice. " Discontinue use and discard any remaining product from this lot in your possession. bioMrieux will replace the product at no charge in accordance with our standard limited warranty. " Confirm the amount of pouches scrapped (if any) on the attached Acknowledgement of Receipt Form. " If you have further distributed this product, please identify any recipients and notify them at once. " Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification. If you require additional assistance or have any questions, please contact your local bioMrieux Customer Service representative or call customer service department at 1-800-736-6354.

    Distribution

    OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel

    Quantity

    29 kits